Autopsy report · NCT00488774

An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis

“Protocol was cancelled by company based on overall efficacy, no safety concern”

The sponsor’s own words in the registry.

Life of this trial

• Registered 2 months before it started.
• Ran for about 1 year 9 months before it stopped.
• 291 participants enrolled.
• Results were posted on the registry 4 years 1 month after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2, Phase 3

Sponsor

Janssen Research & Development, LLC

Sponsor type

Industry

Conditions

Colitis, Ulcerative

Interventions

Placebo; Golimumab 1 mg per kg; Golimumab 2 mg per kg; Golimumab 4 mg per kg

Participants

291

Sites

108

Countries

Australia, Austria, Belgium, Bulgaria, Canada, France, Germany, Hungary, India, Israel, Latvia, Lithuania and more

Trials that died the same way

• Nilotinib With Chemotherapy for the Treatment of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
  “The study was terminated due to excessive toxicity and low compliance to the protocol scheme.” (77% match in meaning)
• Safety, Tolerability, and Pharmacokinetics of AMG 827 in Adolescents With Asthma
  “The study had been cancelled and replaced with protocol 20130250.” (68% match in meaning)
• Inhaled Sodium Nitrite as an Antimicrobial for Cystic Fibrosis
  “Protocol closed due to difficulty recruiting subjects and then expiration of investigational product and lack of a manufacturer.” (67% match in meaning)
• Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole
  “This study was terminated for reasons not related to efficacy or safety” (66% match in meaning)
• A Dose Exploration Study With Birabresib (MK-8628) in Participants With Selected Hematologic Malignancies (MK-8628-005)
  “This study was terminated due to limited efficacy and not due to safety reasons” (65% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.